Treating ulcerative colitis with brazikumab

Abstract

The disclosure relates to products and methods for treating ulcerative colitis. The products relate to antibodies that inhibit native human IL-23, but do not inhibit IL-12.

What is claimed is: 
     
         1 . A method of treating ulcerative colitis in a subject comprising administering a therapeutically effective amount of an anti-IL-23 antibody that does not inhibit IL-12 to a subject with ulcerative colitis. 
     
     
         2 . The method of  claim 1  wherein the subject has moderately to severely active ulcerative colitis as determined by a colonoscopy. 
     
     
         3 . The method of  claim 1  wherein the anti-IL-23 antibody is administered by intravenous infusion. 
     
     
         4 . The method of  claim 3  wherein a total dosage of at least 700 mg, at least 1400 mg, at least 2100 mg, or at least 4200 mg of anti-IL-23 antibody is administered. 
     
     
         5 . The method of  claim 3  wherein the intravenous infusion comprises at least 70 mg of anti-IL-23 antibody in a volume of about 100 ml delivered over a period of at least 30 minutes. 
     
     
         6 . The method of  claim 1  wherein a plurality of intravenous infusions is administered. 
     
     
         7 . The method of  claim 6  wherein the plurality of intravenous infusions each comprise the same quantity of anti-IL-23 antibody. 
     
     
         8 . The method of  claim 1  wherein the anti-IL-23 antibody is administered subcutaneously. 
     
     
         9 . The method of  claim 8  wherein the anti-IL-23 antibody is administered in a plurality of doses. 
     
     
         10 . The method of  claim 9  wherein a total dosage of at least 105 mg or at least 210 mg of anti-IL-23 antibody is administered. 
     
     
         11 . The method of  claim 9  wherein each dose comprises about 70 mg anti-IL-23 antibody. 
     
     
         12 . The method of  claim 1  further comprising a plurality of doses of anti-IL-23 antibody, wherein a second dose is administered about two weeks after a first dose, and a third and subsequent doses are administered about four weeks after a preceding dose. 
     
     
         13 . The method of  claim 12  wherein the plurality of doses is about 10 doses. 
     
     
         14 . The method of  claim 12  wherein the first and second doses are administered by intravenous infusion and any subsequent dose is administered subcutaneously. 
     
     
         15 . The method of  claim 13  wherein each dose comprises at least 70 mg of anti-IL-23 antibody. 
     
     
         16 . The method of  claim 1  further comprising measuring the effect of the therapy using the modified Mayo Score/Disease Activity Index for Ulcerative Colitis. 
     
     
         17 . The method of  claim 16  wherein the therapy lowers the score of at least two components of the modified Mayo Score/Disease Activity Index for Ulcerative Colitis, wherein the components are selected from the group consisting of Stool Frequency, Rectal Bleeding, Endoscopy Findings and Physicians' Global Assessment. 
     
     
         18 . The method of  claim 1  wherein the anti-IL-23 antibody comprises the CDRH1 of SEQ ID NO:3, the CDRH2 of SEQ ID NO:4, the CDRH3 of SEQ ID NO:5, the CDRL1 of SEQ ID NO:6, the CDRL2 of SEQ ID NO:7 and the CDRL3 of SEQ ID NO:8. 
     
     
         19 . The method of  claim 1  wherein the anti-IL-23 antibody comprises the heavy chain variable region sequence of SEQ ID NO:1. 
     
     
         20 . The method of  claim 1  wherein the anti-IL-23 antibody comprises the light chain variable region sequence of SEQ ID NO:2. 
     
     
         21 . The method of  claim 1  wherein the anti-IL-23 antibody comprises the heavy chain variable region sequence of SEQ ID NO:1 and the light chain variable region sequence of SEQ ID NO:2.